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Fractional Flow Reserve to Determine the ApproprIateness of Percutaneous Renal Artery Intervention in Atherosclerosis Renovascular Hypertension Patients: a Pilot Randomized Trial
Although randomized trials have demonstrated there is no benefit of renal-artery stenting in addition to medical therapy for patients with atherosclerosis renal artery stenosis, many patients indeed gained benefit in daily practices after stenting, such as reduction in blood pressure and recovery in renal functions. One important gap is that there is no universal standard to determine whether to stent in these patients. Fraction Flow Reserve (FFR) has been studied for many year in chronic coronary heart disease and FFR-guided revascularization strategy is known to be better than both angiography-guided revascularization and medication alone. The goal of this clinical trial is to learn whether Fraction Flow Reserve (FFR) is appropriate to determine stenting in hypertension patients with atherosclerosis renal artery stenosis. The main questions it aims to answer are: * Is it appropriate to use FFR to determine whether or not stenting for hypertension patients with atherosclerosis renal artery stenosis? * To provide detailed data supporting design of further trial, such as sample size calculating, cut-off value for FFR in renal artery stenosis, etc. Participants met the inclusive/exclusive criteria will be randomized to stenting or not in the renal artery, then hyperemic FFR induced by dopamine will be measured in all participants. If FFR is ≥0.80, randomization will be applied. If FFR is \<0.80, randomization will be ignored, and stenting will be performed as planned. The blood pressure and anti-hypertensive medications will be compared before and 3 months after the procedure based on ambulatory blood pressure monitoring, all participants will be followed up for 1 year.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Chao-yang hospital, capital medical university
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Qinghai province cardiovascular and cerebrovascular disease specialist hospital
Xining, Qinghai, China
Zibo Central Hospital
Zibo, Shandong, China
Start Date
January 31, 2023
Primary Completion Date
March 31, 2025
Completion Date
March 31, 2025
Last Updated
June 6, 2024
100
ESTIMATED participants
Dopamine
DRUG
Fractional Flow Reserve, Renal
DIAGNOSTIC_TEST
Renal artery stenting
DEVICE
Lead Sponsor
Peking University First Hospital
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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